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The Accu-Stat™ Home Drug Test for Marijuana (THC), Cocaine (COC), Amphetamine (AMP), Methamphetamine (mAMP), Opiates (OPI), and Phencyclidine (PCP) is a single-unit screening test for the rapid detection of two to six of the above drugs in human urine. The designated cutoff concentrations for these drugs are as follows: Marijuana at 50 ng/ml, Cocaine at 300 ng/ml, Amphetamine at 1000 ng/ml, Methamphetamine at 1000 ng/ml, Opiates at 2000 ng/ml, and Phencyclidine at 25 ng/ml. The tests are intended for over-the-counter (OTC) consumer use as the first step in a two step process that includes confirmatory testing of preliminary positive results. Information, along with the materials for shipping a portion of the urine specimen to the laboratory is provided.

The Accu-Stat™ Home Drug Test for Marijuana, Cocaine, Amphctamine, Methamphetamine, Opiates, and Phencyclidine, like other commercially available drug screening tests, qualitatively measures the presence or absence of THC, COC, AMP, mAMP, OPI, PCP and their metabolites in urine, using a one step, rapid chromatographic immunoassay which operates under the principle of competitive binding. Drugs, which may be present in the urine specimen, compete against the drug conjugate for binding sites on the antibody. During testing, a urine specimen migrates upward by capillary action. Marijuana, if present in the urine specimen below 50 ng/ml, and the other drugs being tested for, if below the cut-off levels stated above, will not saturate the binding sites of the antibody coated particles in the test device. The antibody coated particles will then be captured by immobilized marijuana, cocaine, or other listed drug conjugate and a visible colored line will show up in the test line region. The colored line will not form in the test line region if the marijuana level is above the 50 ng/ml because it will saturate all the binding sites of antimarijuana antibodies. The same holds true for cocaine and the other drugs if the level is above the cut-off. It will saturate all the binding sites of anticocaine (or other drug) antibodies and therefore the colored line will not form in the test region.
A drug-positive urine specimen will not generate a colored line in the test line region because of drug competition, while a drug-negative urine specimen will generate a line in the test region because of the absence of a drug competition. To serve as a procedural control, a colored line will always appear at the control line region if the test has been performed properly.

The provided text describes a 510(k) premarket notification for the Accu-Stat™ Home Drug Test. It details the device's intended use and the basis for its substantial equivalence to predicate devices, but it does not contain a study or data proving the device meets specific acceptance criteria in the format requested.

The document discusses "consumer studies" that demonstrate "excellent overall performance in the hands of lay users" and states that "the data supports the conclusion that the consumer can use the Accu-Stat™ Home Drug Tests." However, it does not provide the specifics of these studies, such as sample size, methodology, or detailed results, nor does it define explicit acceptance criteria with corresponding performance metrics.

Therefore, many of the requested sections cannot be filled from the provided text.

Here's an attempt to answer based on the available information:

1. Table of acceptance criteria and the reported device performance

The document does not explicitly state acceptance criteria in a quantitative format (e.g., sensitivity, specificity thresholds) or present a table of device performance against such criteria. It generally claims "excellent overall performance."

The cut-off concentrations for the drugs are specified, which act as de facto performance targets:

• Marijuana: 50 ng/ml
• Cocaine: 300 ng/ml
• Amphetamine: 1000 ng/ml
• Methamphetamine: 1000 ng/ml
• Opiates: 2000 ng/ml
• Phencyclidine: 25 ng/ml

The operating principle described is that if the drug level is above the cut-off, a line will not form (positive result), and if below, a line will form (negative result).

Reported Device Performance:
The document states: "The consumer studies using the Accu-Stat™ Home Drug Test... demonstrates that the test exhibits excellent overall performance in the hands of lay users." No quantitative data like sensitivity, specificity, or accuracy percentages are provided to back this claim in the given text.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document mentions "consumer studies" but does not specify the sample size, the country of origin of the data, or whether the study was retrospective or prospective.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

The document does not specify the number or qualifications of experts used to establish ground truth for any test sets. The tests are for OTC consumer use, and the "two-step process" includes "confirmatory testing of preliminary positive results" by a laboratory, implying the ground truth for positive cases would be lab-confirmed, but details on this are absent.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not specified in the provided text. The "two-step process" implies an external lab confirmation for positive results, which serves as a form of adjudication for those specific results, but the method for the initial screening interpretations is not detailed.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

There is no mention of a multi-reader multi-case (MRMC) comparative effectiveness study. The device is a rapid chromatographic immunoassay, not an AI-based system. Therefore, the question about human readers improving with AI assistance is not applicable.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This is a qualitative immunoassay test, not an algorithm. Its performance is inherent in its chemical reaction. The "standalone" performance is essentially its ability to react correctly to drug levels. The primary "human-in-the-loop" aspect is the consumer's interpretation of the line, which the document claims is "excellent overall performance in the hands of lay users." However, no specific study data for this standalone performance is provided.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The ground truth implicitly used for positive results would be laboratory confirmatory testing. For negative results, it's the absence of the drug below the cut-off. The document states: "intended for over-the-counter (OTC) consumer use as the first step in a two-step process that includes confirmatory testing of preliminary positive results. Information, along with the materials for shipping a portion of the urine specimen to the laboratory is provided."

8. The sample size for the training set

The document does not refer to a "training set" as this is not an AI/machine learning device.

9. How the ground truth for the training set was established

Not applicable, as there is no "training set" for this type of device.

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The Accu-Stat™ Home Drug Test for Marijuana (THC) is a screening test for the rapid detection of THC and its metabolites in human urine at a cut-off level of 50 ng/ml. The test is intended for over-the-counter (OTC) consumer use as the first step in a two step process to provide consumers with information concerning the presence or absence of THC or its metabolites in a urine sample. Information, along with the materials for shipping a portion of the urine specimen to the laboratory for confirmation testing of a preliminary positive result, the second step in the process, is provided.

The Accu-Stat™ Home Drug Tcst for Marijuana and Cocaine (THC, COC) is a screening test for the rapid detection of THC and/or COC and its metabolites in human urine at a cut-off level of 50 ng/ml for THC and 300 ng/ml for COC. The test is intended for over-the-counter (OTC) consumer use as the first step in a two step process to provide consumers with information concerning the presence or absence of either THC, COC (or their metabolites) in a urine sample. Information, along with the materials for shipping a portion of the urine specimen to the laboratory for confirmation testing of a preliminary positive result, the second step in the process, is provided.

The Accu-Stat™ Home Drug Test for Marijuana (THC) and the Accu-Stat™ Home Drug Test for Marijuana & Cocaine (THC, COC), like other commercially available drug screening tests, qualitatively measures the presence or absence of THC and COC and their metabolites in urine, using a one step, rapid chromatographic immunoassay which operates under the principle of competitive binding. Drugs, which may be present in the urine specimen, compete against the drug conjugate for binding sites on the antibody. During testing, a urine specimen migrates upward by capillary action. Marijuana, if present in the urine specimen below 50 ng/ml, and Cocaine, if present in the urine specimen below 300 ng/ml, will not saturate the binding sites of the antibody coated particles in the test device. The antibody coated particles will then be captured by immobilized marijuana or cocaine conjugate and a visible colored line will show up in the test line region. The colored line will not form in the test line region if the marijuana level is above 50 ng/ml because it will saturate all the binding sites of anti-marijuana antibodies. The same holds true for cocaine if the level is above 300 ng/ml. It will saturate all the binding sites of anti-cocaine antibodies and therefore the colored line will not form in the test region. A drug-positive urine specimen will not generate a colored line in the test line region because of drug competition, while a drug-negative urine specimen will generate a line in the test region because of the absence of a drug competition. To serve as a procedural control, a colored line will always appear at the control line region if the test has been performed properly.

The provided text describes two devices, the Accu-Stat™ Home Drug Test for Marijuana (THC) and the Accu-Stat™ Home Drug Test for Marijuana & Cocaine (THC, COC). It outlines their intended use and claims substantial equivalence to predicate devices, but does not include a detailed study with acceptance criteria and specific performance metrics for the Accu-Stat™ devices themselves.

Instead, the submission states that "The consumer studies using the Accu-Stat™ Home Drug Test for Marijuana (THC) and the Accu-Stat™ Home Drug Test for Marijuana & Cocaine (THC, COC) demonstrates that the test exhibits excellent overall performance in the hands of lay users. The data supports the conclusion that the consumer can use the Accu-Stat™ Home Drug Tests to obtain immediate, preliminary information regarding the possible use of THC and COC."

It further argues for safety and effectiveness by claiming the devices are "identical to the ACON Laboratories One Step Marijuana Test Device and the Multi-Drug Multi-Line Device that is legally marketed under K003557 and K020313 respectively for professional use." This suggests reliance on the predicate devices' performance rather than a new, independent study with specific acceptance criteria reported in this document for the Accu-Stat™ devices.

Therefore, I cannot populate all the requested fields with specific, quantifiable data directly from this document regarding the Accu-Stat™ devices' performance against explicit acceptance criteria. The document claims substantial equivalence and mentions "consumer studies" but does not detail their methodology, results, or the acceptance criteria used.

Based on the provided text, here's what can be extracted and what cannot:

1. A table of acceptance criteria and the reported device performance

• Acceptance Criteria: Not explicitly stated for the Accu-Stat™ devices in this document. The document refers to cut-off levels as part of the device's mechanism: "Marijuana, if present in the urine specimen below 50 ng/ml... and Cocaine, if present in the urine specimen below 300 ng/ml, will not saturate the binding sites..." This describes the functional threshold rather than an acceptance criterion for accuracy or precision.
• Reported Device Performance: The document offers a qualitative statement: "demonstrates that the test exhibits excellent overall performance in the hands of lay users. The data supports the conclusion that the consumer can use the Accu-Stat™ Home Drug Tests to obtain immediate, preliminary information regarding the possible use of THC and COC." No specific numerical performance metrics (e.g., sensitivity, specificity, accuracy percentages) are provided in this text for the Accu-Stat™ devices themselves.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size: Not specified. The document mentions "consumer studies" but does not quantify the sample size.
• Data Provenance: Not specified (e.g., country of origin, retrospective or prospective).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not specified. The document does not describe the establishment of a ground truth for a test set for these specific devices, only mentions that they are "screening tests" and preliminary, requiring confirmation testing.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not applicable as the details of a specific test set study for these devices (beyond "consumer studies") are not provided.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• Not applicable. This device is a rapid immunoassay for drug detection, not an AI-assisted diagnostic device, nor does the document describe a study of human readers.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

• The device is a standalone immunoassay kit intended for "lay users" (consumers) at home without professional human-in-the-loop involvement for initial screening. However, the performance data for such standalone use (e.g., accuracy against a gold standard) is not detailed in this document. The instructions advise a second step of confirmation testing by a lab for positive results.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

• Not specified for the "consumer studies." Given the nature of a drug test, a typical ground truth would be laboratory confirmation using a highly accurate method like GC/MS (Gas Chromatography/Mass Spectrometry). The document only states that the device is the "first step in a two-step process to provide over-the-counter (OTC) consumers... with information regarding the presence of THC or COC and their metabolites in a urine sample. Information regarding the second step, confirmation testing, is provided." This implies that the device offers a preliminary result rather than a definitive ground truth.

8. The sample size for the training set

• Not applicable. This device is an immunoassay, not a machine learning or AI-based system that would typically have a "training set."

9. How the ground truth for the training set was established

• Not applicable for the same reason as above.

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The ACON Spectrum Multi-Drug Multi-Line Drug Screen Test Card and ACON Spectrum Multi-Drug Multi-Line Drug Screen Test Card with three types of Integrated Cups (ACON 006 Cup or RediCup, ACON 008 Cup or iCup and ACON 009 Cup or E-Z Split Key Cup) are rapid chromatographic immunoassays for the qualitative and simultaneous detection of Marijuana, Cocaine, Methamphetamine, Amphetamine, Opiates. Phencyclidine, Benzodiazepine, Methadone, Barbiturate, Tricyclic Antidepressants and Methylenedioxymethamphetamine in human urine at the cutoff concentrations of:

50 ng/mL for Marijuana, 300 ng/mL for Cocaine, 1,000 ng/mL for Methamphetamine, 1,000 ng/mL for Amphetamine, 2,000 or 300 ng/mL for Opiates (OPI2000 or MOP300), 25 ng/mL for Phencyclidine, 300 ng/mL for Benzodiazepine, 300 ng/mL for Methadone, 300 ng/mL for Barbiturate. 1,000 ng/mL for Tricyclic Antidepressants, and 500 ng/mL for Methylenedioxymethamphetamine

These assay systems can only provide a preliminary analytical test result. A more specific alternate chemical must be used in order to obtain a confirmed analytical result. GC/MS is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug of abuse test result, especially when preliminary positive results are indicated.

They are only intended for healthcare professionals including professionals at point of care sites.

The ACON Spectrum Multi-Drug Multi-Line Screen Test Card and ACON Spectrum Multi-Drug Multi-Line Screen Test Card with Integrated Cups (ACON 006 Cup or RediCup, ACON 008 Cup or iCup and ACON 009 Cup or E-Z Split Key Cup) are competitive binding, lateral flow immunochromatographic assays for the qualitative and simultaneous detection of Marijuana, Cocaine, Methamphetamine, Amphetamine, Opiates, Phencyclidine, Antidepressants Benzodiazepine. Methadone, Barbiturate, Tricyclic and Methylenedioxymethamphetamine in human urine at the cutoff concentrations of:

50 ng/mL for Marijuana. 300 ng/mL for Cocaine, 1,000 ng/mL for Methamphetamine, 1,000 ng/mL for Amphetamine, 2,000 or 300 ng/mL for Opiates (OPI2000 or MOP300), 25 ng/mL for Phencyclidine, 300 ng/mL for Benzodiazepine, 300 ng/mL for Methadone, 300 ng/mL for Barbiturate, 1,000 ng/mL for Tricyclic Antidepressants, and 500 ng/mL for Methylenedioxymethamphetamine.

These tests can be performed without the use of an instrument.

A positive urine specimen will not generate a colored-line for the specific drug tested in the designated test region. A negative urine specimen or a urine specimen containing of Marijuana, Cocaine, Methamphetamine, Amphetamine, Opiates, Phencyclidine, Benzodiazepine, Methadone, Barbiturate, Tricyclic -Antidepressants and Methylenedioxymethamphetamine at the concentrations below the designated cut-off levels will generate a colored-line in the designated test region for the drug. To serve as a procedural control, a colored-line will always appear at the control region, indicating that proper volume of specimen has been added and membrane wicking has occurred.

The acceptance criteria and device performance information for the ACON Spectrum Multi-Drug Multi-Line Screen Test Card is derived from the provided text.

1. Table of Acceptance Criteria and Reported Device Performance:

The document describes performance in terms of the ability of the device to detect specific drugs at or above certain cutoff concentrations. The "acceptance criteria" for a qualitative immunoassay like this are inherently tied to its ability to correctly identify positive and negative samples relative to these cutoffs.

2. Sample Size Used for the Test Set and Data Provenance:

The provided text does not explicitly state the sample size used for the test set or the data provenance (e.g., country of origin, retrospective or prospective nature of the study). It describes the device and its intended use but does not detail the specific performance study results, including the number of samples tested to demonstrate its accuracy against the stated cutoffs.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of those Experts:

The text does not mention the number or qualifications of experts used to establish ground truth for any test set. For this type of device, ground truth would typically be established by a reference chemical method (e.g., GC/MS), not by expert human interpretation of the device results.

4. Adjudication Method for the Test Set:

Since there's no mention of a test set being interpreted by human experts or clinical adjudication, there is no adjudication method described in the document.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size of how much human readers improve with AI vs without AI assistance:

This device is a rapid chromatographic immunoassay, not an AI-powered diagnostic imaging or interpretation tool. Therefore, a multi-reader multi-case (MRMC) comparative effectiveness study focusing on human reader improvement with AI assistance was not done and is not applicable to this device.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:

The device itself is a standalone test; it's a "rapid chromatographic immunoassay" that can be "performed without the use of an instrument." The performance described ("A positive urine specimen will not generate a colored-line...") is the standalone performance of the device in detecting the drug. The results are visually interpreted by a healthcare professional, but the core detection mechanism is the autonomous chemical reaction within the test card.

7. The Type of Ground Truth Used:

The type of ground truth used for such a device is implied to be chemical confirmation, specifically GC/MS (Gas Chromatography/Mass Spectrometry). The document states: "A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. GC/MS is the preferred confirmatory method." This indicates that GC/MS serves as the gold standard for confirming the presence or absence of the drugs and their concentrations, against which the immunoassay's performance would be compared.

8. The Sample Size for the Training Set:

The provided text does not mention a training set sample size. This type of immunoassay device is developed through chemical and biological formulation and optimization, not typically through machine learning from a "training set" in the computational sense.

9. How the Ground Truth for the Training Set was Established:

As there is no mention of a training set in the context of machine learning, there is no information on how ground truth for a training set was established. The development and "training" of this type of device would involve laboratory testing with known concentrations of analytes and interferents to optimize the chemical reagents and physical design for accurate detection at the specified cutoffs.

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